EuroPainClinics® Study IV (Prospective Observational Study)
NCT ID: NCT03039296
Last Updated: 2022-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
4 participants
OBSERVATIONAL
2017-02-03
2021-12-31
Brief Summary
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Detailed Description
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EuroPainClinics® Study IV (EPCS IV) is a prospective observational comparative study that will use pain scales to analyse changes in the neurological status of nerves of patients who undergo the minimally invasive procedure: radiofrequency nerve ablation and cryoablation of the lumber facet joints.
The study aims to investigate documented clinical results of the neurological conditions of patients, to compare pain scales and the use of analgesics over a number of time periods: prior to the procedure, 6 weeks post-procedure, as well as 6 and 12 months post-procedure. The data will be subsequently statistically analysed.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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One side endoscopic rhizotomy
Endoscopic rhizotomy will be provided only on one back side according pain
Endoscopic rhizotomy
Endoscopic rhizotomy (facet joint denervation) is carried out through the insertion of an endoscope to the medial spinal nerve area with the help of mobile C-arm x-ray guidance. The tissue surrounding the medial nerves is endoscopically visualized and dissected with a sterile grasper to expose the nerve structure. Finally, a radiofrequency probe is used to ablate the problematic medial branch nerve under direct endoscopic control. The procedure is concluded with the removal of the endoscope and the small incision is closed with 1-2 skin sutures.
Both sides endoscopic rhizotomy
Endoscopic rhizotomy will be provided on both back sides according pain
Endoscopic rhizotomy
Endoscopic rhizotomy (facet joint denervation) is carried out through the insertion of an endoscope to the medial spinal nerve area with the help of mobile C-arm x-ray guidance. The tissue surrounding the medial nerves is endoscopically visualized and dissected with a sterile grasper to expose the nerve structure. Finally, a radiofrequency probe is used to ablate the problematic medial branch nerve under direct endoscopic control. The procedure is concluded with the removal of the endoscope and the small incision is closed with 1-2 skin sutures.
Interventions
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Endoscopic rhizotomy
Endoscopic rhizotomy (facet joint denervation) is carried out through the insertion of an endoscope to the medial spinal nerve area with the help of mobile C-arm x-ray guidance. The tissue surrounding the medial nerves is endoscopically visualized and dissected with a sterile grasper to expose the nerve structure. Finally, a radiofrequency probe is used to ablate the problematic medial branch nerve under direct endoscopic control. The procedure is concluded with the removal of the endoscope and the small incision is closed with 1-2 skin sutures.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Europainclinics z.ú.
OTHER
Responsible Party
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Principal Investigators
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Locations
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Europainclinics
Košice, , Slovakia
Countries
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Other Identifiers
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5N/2016
Identifier Type: -
Identifier Source: org_study_id
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